68475-204-04 : NDC 2026 Code

68475-204-04 : Miglustat ( Miglustat )

NDC Code : 68475-204-04 – XML Data Format

                    
<?xml version="1.0" encoding="UTF-8"?>
<NDC>
	<NDCCode>
		68475-204-04
	</NDCCode>
	<PackageDescription>
		4 BLISTER PACK in 1 CARTON (68475-204-04)  / 21 CAPSULE in 1 BLISTER PACK (68475-204-03) 
	</PackageDescription>
	<NDC11Code>
		68475-0204-04
	</NDC11Code>
	<ProductNDC>
		68475-204
	</ProductNDC>
	<ProductTypeName>
		HUMAN PRESCRIPTION DRUG
	</ProductTypeName>
	<ProprietaryName>
		Miglustat
	</ProprietaryName>
	<ProprietaryNameSuffix/>
	<NonProprietaryName>
		Miglustat
	</NonProprietaryName>
	<DosageFormName>
		CAPSULE
	</DosageFormName>
	<RouteName>
		ORAL
	</RouteName>
	<StartMarketingDate>
		20250507
	</StartMarketingDate>
	<EndMarketingDate/>
	<MarketingCategoryName>
		ANDA
	</MarketingCategoryName>
	<ApplicationNumber>
		ANDA219111
	</ApplicationNumber>
	<LabelerName>
		Navinta LLC
	</LabelerName>
	<SubstanceName>
		MIGLUSTAT
	</SubstanceName>
	<StrengthNumber>
		100
	</StrengthNumber>
	<StrengthUnit>
		mg/1
	</StrengthUnit>
	<Pharm_Classes>
		Enzyme Stabilizer [EPC], Enzyme Stabilizers [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA]
	</Pharm_Classes>
	<DEASchedule/>
	<Status>
		Active
	</Status>
	<LastUpdate>
		2026-01-02
	</LastUpdate>
	<PackageNdcExcludeFlag>
		N
	</PackageNdcExcludeFlag>
	<ProductNdcExcludeFlag>
		N
	</ProductNdcExcludeFlag>
	<ListingRecordCertifiedThrough>
		20261231
	</ListingRecordCertifiedThrough>
	<StartMarketingDatePackage>
		20251223
	</StartMarketingDatePackage>
	<EndMarketingDatePackage/>
	<SamplePackage>
		N
	</SamplePackage>
</NDC>

                    
                

NDC XML XSD Schema

                    
<xs:schema attributeFormDefault="unqualified" elementFormDefault="qualified" xmlns:xs="http://www.w3.org/2001/XMLSchema">
  <xs:element name="NDC">
    <xs:complexType>
      <xs:sequence>
        <xs:element type="xs:string" name="NDCCode"/>
        <xs:element type="xs:string" name="PackageDescription"/>
        <xs:element type="xs:string" name="NDC11Code"/>
        <xs:element type="xs:string" name="ProductNDC"/>
        <xs:element type="xs:string" name="ProductTypeName"/>
        <xs:element type="xs:string" name="ProprietaryName"/>
        <xs:element type="xs:string" name="ProprietaryNameSuffix"/>
        <xs:element type="xs:string" name="NonProprietaryName"/>
        <xs:element type="xs:string" name="DosageFormName"/>
        <xs:element type="xs:string" name="RouteName"/>
        <xs:element type="xs:string" name="StartMarketingDate"/>
        <xs:element type="xs:string" name="EndMarketingDate"/>
        <xs:element type="xs:string" name="MarketingCategoryName"/>
        <xs:element type="xs:string" name="ApplicationNumber"/>
        <xs:element type="xs:string" name="LabelerName"/>
        <xs:element type="xs:string" name="SubstanceName"/>
        <xs:element type="xs:string" name="StrengthNumber"/>
        <xs:element type="xs:string" name="StrengthUnit"/>
        <xs:element type="xs:string" name="Pharm_Classes"/>
        <xs:element type="xs:string" name="DEASchedule"/>
        <xs:element type="xs:string" name="Status"/>
        <xs:element type="xs:string" name="LastUpdate"/>
        <xs:element type="xs:string" name="PackageNdcExcludeFlag"/>
        <xs:element type="xs:string" name="ProductNdcExcludeFlag"/>
        <xs:element type="xs:string" name="ListingRecordCertifiedThrough"/>
        <xs:element type="xs:string" name="StartMarketingDatePackage"/>
        <xs:element type="xs:string" name="EndMarketingDatePackage"/>
        <xs:element type="xs:string" name="SamplePackage"/>
      </xs:sequence>
    </xs:complexType>
  </xs:element>
</xs:schema>